1. Field of the Invention
The present invention relates to a mouldable mass for use in connection with an ostomy appliance or fistulas, to a method for preparing such a mouldable mass and to the use of a mouldable mass to provide a smooth surface on which an ostomy appliance is to be applied or for use in connection with fistulas.
2. Description of the Related Art
In connection with surgery for a number of diseases in the gastro-intestinal tract, a consequence is, in many cases, that the colon, the ileum or the urethra has been exposed surgically and the patient is left with an abdominal stoma and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Also, in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
Often, a paste is used for filling the area between the stoma or fistula and a mounting gasket, ostomy washer and/or skin barrier or to build up an area on the abdomen around the stoma so as to provide a relatively flat and smooth surface onto which an appliance or skin barrier can be securely attached.
Such paste should have a composition which is sufficiently tacky to secure the appliance or skin barrier to the abdomen, and a cohesion ensuring safe removal thereof without leaving residues on the skin. On the other hand, the paste must not be so sticky that it cannot be easily shaped by the finger or hand without sticking to the finger or hand. Furthermore, the paste must show a sufficient elasticity in order to be able to follow the movements of the patient without slipping on the skin and should also show a great resistance to erosion caused by aggressive exudates from an ostomy in order to minimize the risk of leakage.
Pastes for use for protecting the area of skin between the stoma and an attached appliance, face plate or skin barrier and for providing a smooth abdominal surface around the stoma for attachment of a skin barrier or appliance are known from EP Patent No. EP 0 048 556 B1 and U.S. Pat. No. 4,204,540
Thus, European Patent No. EP 0 048 556 B1 discloses a composition of paste-like consistency useful for protecting and treating the skin contiguous to a stoma in the form of an alcohol based composition including as a film former the partial ester of the polycarboxylic resin formed from vinyl methyl ether and maleic anhydride, one or more hydrocolloid gums, one or more gelling and thickening agents, a plasticizer, and other optional ingredients.
The composition disclosed in EP 0 048 556 B1 suffers from the drawback that it comprises a considerable amount (25% to 45% by weight) of alcohol, ethanol and isopropanol being preferred. When using such a paste, there is only a limited time for forming the paste after the application as the paste cures when exposed to air. Furthermore, the paste shows less attractive physical properties as a considerable amount of alcohol may be trapped in the paste and have an adverse effect on the properties of the adhesive of an ostomy appliance which is placed upon the paste. Still further, the considerable amount of alcohol may irritate the skin and cannot be used on skin which has been sensibilized.
The method of protecting the area of skin between the stoma and an attached appliance, face plate or skin barrier and for providing a smooth abdominal surface around the stoma for attachment of a skin barrier or appliance disclosed in U.S. Pat. No. 4,204,540 comprises shaping and placing around the stoma the shaped mass. The mass comprises a homogeneous mixture of mineral oil, a premix comprising (A) a pressure sensitive adhesive and an optional elastomer wherein the pressure sensitive adhesive is a low molecular weight polyisobutylene and the optional elastomer is a medium molecular weight polyisobutylene or butyl rubber, and (B) a second component which is a mixture of one or more hydrocolloid gums, a cohesive strengthening agent or a mixture of hydrocolloid gums and cohesive strengthening agent wherein the hydrocolloids are up to 40% guar gum, locust bean gum or mixtures thereof and from 0 to 25% pectin, gum karaya or mixtures thereof, and wherein the cohesive strengthening agent is finely divided cellulose, finely divided substantially water insoluble sodium carboxymethyicellulose or finely divided water insoluble starch-acrylonitrile graft copolymer. It is stated that by controlling the amount of mineral oil the resulting composition can easily be shaped according to the particular need. The pressure sensitive adhesive is based on natural or synthetic viscous substances either possessing dry tack by themselves or developing such tack upon the addition of a plasticizer.
The pastes disclosed in U.S. Pat. No. 4,204,540 suffer from the drawback that the shapeability is very dependant of the content of mineral oil. If an insufficient amount of mineral oil is added, the composition will be too tough to shape and if too much mineral oil is added the composition becomes sticky and difficult to handle. Generally, pastes consisting of polyisobutylene, butyl rubber and mineral oil will be very hard, if the content of butyl rubber is high and hence, the paste will be difficult to shape, or it will be very soft and liquid if the content of butyl rubber is low and the content of mineral oil is high.
U.S. Pat. No. 5,492,943 discloses a pressure sensitive adhesive composition including a blend of two viscoelastic adhesive elastomers, specifically, high molecular weight polyisobutylene and a styrene block copolymer, which along with a plasticizer (preferably petrolatum) and a suitable tackifier and antioxidant, form a continuous phase in which hydrocolloids such as sodium carboxymethylcellulose and pectin are dispersed. The adhesive compositions disclosed in U.S. Pat. No. 5,492,943 are stated to be used for wafers for adhering ostomy appliances to the skin and differ from known compositions by completely avoiding the use of low molecular weight polyisobutylene and furthermore by preferably not including gelatin.